FDA Inspection 628713 — White Plains Hospital Center Blood Bank
The FDA completed an inspection of White Plains Hospital Center Blood Bank on November 23, 2009 in White Plains, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 23, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- White Plains, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9227 | 21 CFR 606.171(a) | BPDR - procedures |